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Notice Extend Expiration Date PAR-11-173 quot;NINDS PHASE III Investigator-Initiated Multi-Site Clinical Trials U01)" Notice Number: NOT-NS-13-023 Key Dates Release Date:   March 25, 2013   Related Announcements PAR-11-173 Issued National Institute Neurological Disorders Stroke NINDS) Purpose NINDS gives notice the extension the expiration date PAR-11-173 quot;NINDS PHASE III Investigator-Initiated Multi-Site Clinical Trials U01)" until September 8, 2013. other aspects the FOA remain unchanged. Inquiries Please direct inquiries to: Scott Janis, PhD National Institute Neurological Disorders Stroke Telephone: 301) 496-9135 Email: Scott.Janis@nih.gov

Pre-application Information Webinars the NINDS Stroke Trials Network Notice Number: NOT-NS-13-021 Key Dates Release Date: March 22, 2013 Related Announcements RFA-NS-13-011 RFA-NS-13-012 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to inform potential applicants pre-application webinars provide submission information the NINDS Stroke Trials Network. new network designed develop conduct high-quality, multi-site clinical trials focused key interventions stroke prevention, treatment, recovery the objective have balanced portfolio between three approaches.  Exploratory phase 1, 2 confirmatory phase 3 clinical trials well biomarker-validation studies are immediately preparatory trials be coordinated through separate National Clinical Coordinating Data Management Centers. intent the webinars to provide overview the initiative to address questions pertinent preparing applications.  webinars optional not required application submission. Webinars Information Date: Monday, April 1, 2013 Time: 12:00 PM - 1:00 PM EDT Meeting URL: https://www2.gotomeeting.com/join/407718530 Call-in number: 800-779-5339 Participant passcode: 53789 Date: Friday, April 5, 2013 Time: 12:00 PM - 1:00 PM EDT Meeting URL: https://www2.gotomeeting.com/join/521813330 Call-in number: 800-779-5339 Participant passcode: 53789 Space limited. Questions be submitted email either beforehand during webinar.  Please put Webinar question” the subject line, send the following email address: Stroke_Network@mail.nih.gov. While every effort be to answer questions during webinar, is possible not will addressed during meeting due time constraints. applicants strongly encouraged discuss applications the appropriate NIH Scientific/Research Contact Financial/Grants Management Contact listed the FOA early possible. complete text the FOAs available http://grants.nih.gov/grants/guide/rfa-files/RFA-NS-13-011.html http://grants.nih.gov/grants/guide/rfa-files/RFA-NS-13-012.html. Inquiries Please direct inquiries to: Scott Janis, PhD Program Director NINDS Office Clinical Research Telephone: 301-496-9135 Email: Scott.Janis@nih.gov

Notice Modification the Data Sharing Policy the Federal Interagency Traumatic Brain Injury Research FITBIR) Informatics System Notice Number: NOT-NS-13-018 Key Dates Release Date:  March 21, 2013 Related Announcements NOT-NS-12-016 NOT-NS-12-017    Issued National Institute Neurological Disorders Stroke NINDS) Purpose Data Sharing Policy the Federal Interagency Traumatic Brain Injury Research FITBIR) Informatics System modified. overall document been shortened reorganized make clearer more concise.  Also, Data Submission Data Sharing Schedules been modified greater clarity feasibility follows:   Data Submission Schedule Data include research clinical assessments information obtained via interviews, direct observations, laboratory tasks procedures, records reviews, genetic genomic data, neuroimaging data, neuropsychological assessments, data physical examinations, etc. addition, supporting documentation is needed enable investigator unfamiliar the dataset understand use data also required.  example, supporting documentation include non-copyrighted data collection forms, study procedures protocols, data dictionary rationale, exclusion criteria, website references, listing major study publications, the definition a genomic analysis protocol.  following not included data:  laboratory notebooks, preliminary analyses, drafts scientific papers, plans future research, peer review reports, communications colleagues, physical objects, such gels laboratory specimens. data be submitted FITBIR a quarterly basis according the following schedule: Data collection period Quarterly upload due: January 1 – March 31 June 30 April 1 – June 30 September 30 July 1 – September 30 December 31 October 1 – December 31 March 31 Data Sharing Schedule Six months after end the performance period the grant, data be available other researchers have submitted data FITBIR Submitters). Twelve months after end the grant contract, data be open all qualified approved researchers Recipients). Performance Period Research Study Ends Data Available FITBIR Submitters” Data Available All Approved FITBIR Data Recipients” Time 0   6 months 12 months Investigators also strongly encouraged collaborate share data throughout study accelerate research advance knowledge TBI. Inquiries Please direct inquiries to: FITBIR Operations Team Email: FITBIR-ops@mail.nih.gov Website: https://fitbir.nih.gov/ 

Notice Change Eligibility Foreign Institutions NINDS RFA-NS-13-013 quot;Collaborative Research Chronic Traumatic Encephalopathy Delayed Effects Traumatic Brain Injury: Neuropathology Neuroimaging Correlation U01)" Notice Number:  NOT-NS-13-019 Key Dates Release Date:  March 21, 2013 Related Announcements RFA-NS-13-013    Issued National Institute Neurological Disorders Stroke NINDS) Purpose National Institute Neurological Disorders Stroke NINDS) expanding institutional eligibility RFA-NS-13-013 quot;Collaborative Research Chronic Traumatic Encephalopathy Delayed Effects Traumatic Brain Injury: Neuropathology Neuroimaging Correlation U01)" include foreign components within applications US entities. Part II. Section III.1 Eligible Applicants CURRENTLY READS: Foreign Institutions Non-domestic non-U.S.) Entities Foreign Institutions) not eligible apply. Non-domestic non-U.S.) components U.S. Organizations not eligible apply. Foreign components, defined the NIH Grants Policy Statement, not allowed CHANGED READ: Foreign Institutions Non-domestic non-U.S.) Entities Foreign Institutions) not eligible apply. Non-domestic non-U.S.) components U.S. Organizations not eligible apply. Foreign components, defined the NIH Grants Policy Statement, allowed. other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Ramona Hicks, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1447 Email: hicksra@mail.nih.gov

Plan Include Parkinson's Disease Biomarkers Projects the NINDS Parkinson's Disease Biomarkers Program PDBP) Notice Number: NOT-NS-13-020 Update: following update relating this announcement been issued: 8, 2014 - Notice NOT-NS-14-027. Notice Intent Publish Funding Opportunity Announcement Biomarker Discovery through Use Data Resources Developed the NINDS Parkinson's Disease Biomarker Program PDBP) U01). Key Dates Release Date: March 20, 2013 Issued National Institute Neurological Disorders Stroke NINDS) Purpose creation the NINDS Parkinson’s Disease Biomarkers Program PDBP) resulted an opportunity a common platform exchanging data, protocols, biospecimens Parkinson’s Disease PD) Biomarkers Research. NINDS expects projects studying Parkinson’s Disease biomarkers utilize PDBP Data Management Resource DMR), NINDS created order accelerate progress this field. Background overall goal the NINDS Parkinson’s Disease Biomarkers Program PDBP)  to allow rapid identification development potential biomarkers improve efficiency outcome Phase II III clinical trials neuroprotective agents Parkinson’s Disease.  order accomplish goal, is essential there a concerted effort collect biospecimens, imaging, clinical data using standardized approaches.  Furthermore, collaborative environment be essential success this program; therefore sharing standards policies been established. Brief Summary PDBP Policies Details regarding PDBP structure policies be found https://pdbp.ninds.nih.gov/index.jsp.  brief selection policy highlights includes: Clinical laboratory data expected be entered and shared via PDBP Data Management Resource DMR). Costs related utilization this resource, any costs associated the inclusion legacy data, should included the application budget. Clinical studies expected use core set defined NINDS Clinical Data Elements CDEs), https://pdbp.ninds.nih.gov/jsp/healthcare-professionals.jsp. Note clinical trials interventional studies) not included the PDBP. studies have both interventional a biomarkers component, latter component be expected participate per specifications this notice the PDBP. Consent forms clinical studies should consistent those listed https://pdbp.ninds.nih.gov/assets/PDBP%20DMR%20Consent%20Elements.pdf. eligible biological specimens expected be banked the NINDS Repository. Sharing data biospecimens qualified researchers both academics industry expected.    Selected NINDS grantees be invited attend meetings per year discuss PDBP progress policy, be included the PDBP Steering Committee, a part the consortium. Plans the costs attending to PDBP organizational meetings per year should included the application budget. Implementation policy apply all NINDS projects PD Biomarkers research including R01, U01, P50, P01, other mechanisms). Because extensive programmatic input coordination required NINDS PDBP projects, successful applications be converted cooperative agreements U mechanism). Applicants are proposing PD biomarker studies urged contact NINDS program director prior submission order allow ample planning coordination the PDBP with PDBP policies. Inquiries Please direct inquiries to: Katrina Gwinn, MD Program Director Division Extramural Research National Institute Neurological Disorders Stroke Telephone: 301-496-5745 Email: gwinnk@ninds.nih.gov Website: Pdbp.ninds.nih.gov

Notice Correction Regarding Application Instructions PAR-13-116 NINDS Institutional Center Core Grants Support Neuroscience Research P30)" Notice Number:  NOT-NS-13-017 Key Dates Release Date: February 21, 2013 Related Announcements RFA-NS-14-013 PAR-13-116 Issued National Institute Neurological Disorders Stroke NINDS) Purpose Notice provides supplemental instructions Section IV.2 Application Submission Information) PAR-13-116. Part 2. Section IV.2. Application Submission Information Budget Allowable Costs: Salary support the PD(s)/PI(s) not exceed 0.6 calendar months.  Support secretarial administrative staff be requested the extent it contributes substantially the management the Center.  Costs PD(s)/PI(s) salary support secretarial administrative staff not exceed 10% the total direct costs a Center any year. Salary not requested PD(s)/PI(s) qualifying projects directors individual cores within Center. Salary be requested technical support personnel consultants. Requests shared equipment allowed. Consumable supplies be requested the extent directly contribute the operation the cores are project specific.  Unique research reagents supplies are specific the support individual projects, including experimental animals, not requested. Costs animal purchase care only allowed limited circumstances required core operations, are allowed furtherance specific projects. Travel costs not allowed. Patient care recruitment costs not allowed. Costs seminars workshops not allowed. Alteration renovation costs not allowed. other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Edmund Talley, Ph.D. National Institute Neurological Disorders Stroke NINDS) 6001 Executive Blvd, Bethesda, MD 20892 Telephone: 301-496-1917 Email strongly preferred): TalleyE@mail.nih.gov

Notice Correction Application Submission Instructions RFA-NS-13-009 quot;High Impact Neuroscience Research Resource Grants R24)" Notice Number:  NOT-NS-13-016 Key Dates Release Date: February 20, 2013 Related Notices RFA-NS-13-009 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to correct application submission instructions the Budget form RFA-NS-13-009 quot;High Impact Neuroscience Research Resource Grants R24)". Funding Opportunity Announcement FOA) currently states: Part II. Section IV.2 Application Submission Information Budget applications must the R&R Budget forms regardless the direct costs each budget year. Applicants ignore following warning during submission process: direct cost requests 250K less year the 424 R&R Budget page section F-K) must in modules 25K, using PHS 398 Modular Budget Form not R&R Budget Form. Incorrect applications be delayed the peer review process rejected.”  FOA modified state: Part II. Section IV.2 Application Submission Information Budget applications must contain detailed budget. other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Edmund Talley, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1917 Email strongly preferred): TalleyE@mail.nih.gov

Notice Intent Publish Funding Opportunity Announcement the NINDS Research Education Program Residents Fellows Neurology, Neurosurgery, Neuropathology Neuroradiology R25) Notice Number: NOT-NS-13-012 Key Dates Release Date:   February 13, 2013 Estimated Publication Date Announcement: Summer 2013  First Estimated Application Due Date: Fall 2013  Earliest Estimated Award Date: Spring 2014  Earliest Estimated Start Date: Spring 2014  Related Announcements RFA-NS-12-003 Issued National Institute Neurological Disorders Stroke NINDS) Purpose National Institute Neurological Disorders Stroke NINDS) intends release new Funding Opportunity Announcement FOA) receipt new renewal applications its research education program residents fellows Neurology, Neurosurgery, Neuropathology Neuroradiology. Notice being provided allow potential applicants sufficient time plan and prepare applications.  FOA expected be published the summer 2013, an expected receipt date the fall 2013. programmatic details expected be largely similar those described the previously issued Funding Opportunity Announcement RFA-NS-12-003 used solicit applications this program. FOA utilize R25 activity code. APPLICATIONS NOT BEING SOLICITED THIS TIME. Inquiries Please direct inquiries to: Stephen Korn, Ph.D. Chief, Office Training, Career Development Workforce Diversity National Institute Neurological Disorders Stroke, NIH Email: korns@ninds.nih.gov

Notice Correction the Instructions the Submission the Eligibility Certification Letter PAR-12-152 quot;NINDS Faculty Development Award Promote Diversity Neuroscience K01)" Notice Number: NOT-NS-13-014 Key Dates Release Date: February 11, 2013    Related Notices PAR-12-152 Issued National Institute Neurological Disorders Stroke NINDS) Purpose Notice corrects application instruction regarding submission a required letter certifying eligibility the K01 applicant this program. Specifically, applicant institution must submit letter certifying the applicant belongs one the diversity groups currently underrepresented the neuroscience research workforce a national basis further defined PAR-12-152 Section III.1 Eligible Individuals). instructions currently state: Information must submitted the applicant Institution a letter certifying the applicant belongs one the above groups. letter should inserted the application immediately before Checklist a PDF file. instructions SHOULD state: certification letter titled: Diversity_Eligibility_Ltr) must attached via quot;Other Attachments" the SF424 Project Information form.  letter must on institutional letterhead scanned that institutional official signature visible. other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Michelle Jones-London, Ph.D. National Institute Neurological Disorders Stroke Phone: 301) 451-7966 Email: jonesmiche@ninds.nih.gov

NINDS Policy Submission Applications Containing Clinical Trials Notice Number: NOT-NS-13-006 Update: following update relating this announcement been issued: July 20, 2016 - Notice been replaced NINDS Policy Submission Applications Containing Clinical Trials. Notice NOT-NS-16-034. July 22, 2013 - Issuance PAR-13-278, NINDS Phase III Investigator-Initiated Efficacy Clinical Trials U01). Key Dates Release Date:  February 6, 2013 Related Notices Notice replaces NOT-NS-12-007 PA-11-260 PAR-10-199 PAR-11-173 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to define types clinical studies may submitted NINDS response the NIH parent R01 Funding Opportunity Announcement FOA) PA-11-260 subsequent revisions this FOA.  NINDS not accept investigator initiated R01 applications include clinical trials under PA-11-260.  clinical trial a prospective biomedical behavioral research study human subjects designed answer specific questions the safety, tolerability, efficacy and/or effectiveness pharmacologic, behavioral, biologic, surgical, device invasive non-invasive) interventions.  policy applies only clinical trials submitted PA-11-260 investigator initiated R01 applications subsequent revisions.  policy does apply 1) NINDS-specific announcements specifically solicit clinical trials, 2) exploratory IND studies defined the FDA http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformat…) 3) early feasibility studies devices defined the FDA http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance…).  Applicants submitting investigator initiated applications NINDS contain clinical trial must submit one the following NINDS FOAs specifically designed clinical trials: NINDS Exploratory Clinical Trials R01) PAR-10-199 NINDS PHASE III Investigator-Initiated Multi-Site Clinical Trials U01) PAR-11-173 Inquiries Please direct inquiries to: Crina Frincu, PhD Office Clinical Research National Institute Neurological Disorders Stroke Neuroscience Center, Room 2210 6001 Executive Boulevard Bethesda, MD 20892 Telephone: 301) 496-9135 Fax: 301) 410-1080 Email:  CRLiaison@ninds.nih.gov